30 days old

Quality Assurance Manager

Andover, MA 01810
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**Why Patients Need You**

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

**What You Will Achieve**

You will be a member of Pfizer's dedicated and highly effective quality assurance team. You will evaluate and review Pfizer's clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

**How You Will Achieve It**

Working as a partner with Quality Control (QC), Pharm Sci, STS, and other organizations as appropriate. The Quality Assurance Manager is responsible for all Drug Substance QC testing, Quality Agreements, Investigations, and various other quality systems required to support QC and the Andover site. Additionally, the QA Manager is accountable for the assurance that all activities related to the Quality Control lab and the Site is in compliance. Strong communications and leadership skills are needed to be successful in this role.

+ Leads the efforts of QA personnel responsible for the testing, investigations, procedures and method transfer activities to ensure compliance with all regulatory requirements, company policies, values, and goals.

+ Responsible for approving quality record review such as investigations, CAPAs, Change Controls and other quality documents as required.

+ Responsible for driving process improvements within Drug Substance, Drug Product, Site support systems.

+ Actively drives with urgency when necessary to resolve issues related to production or supply as it relates to investigations or other issues.

+ Escalates issues with urgency and proposed solutions to resolve the issue quickly.

+ Responsible for driving cross-training across Drug Substance, Drug Product, Site staff resources (as well as potentially other areas of QA).

+ Responsible for inspection support and SME for QA QC Site department as required.

+ Responsible for oversight of Site investigations, procedures, and general areas related to facilities and other areas.

+ Partners with other QA managers to ensure consistency and efficiency within the QA department.

+ This position requires strong collaboration skills, including working with Pharm Sci QA, Quality Control, Engineering, Site Technical Services and others to ensure timelines are met for activities related to Quality Control and the Site.

+ Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.

+ Participates in the recruitment, selection, promotion, termination, and performance management of QA employees

+ Other duties as required.



+ Bachelor's Degree in Chemistry, Engineering, Biology, Manufacturing Management, or related field required.

+ 10+ years of experience in pharma/biopharma industry required.

+ 3+ years of management experience required.

+ Strong collaboration, relationship management, and interpersonal skills.

+ Excellent written and oral communication skills

+ Strong computer proficiency skills


+ Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision

**Physical/Mental Requirements**

+ Ability to gown and enter the manufacturing Suite as needed or QC Labs.

**Non-Standard Work Schedule, Travel, or Environment Requirements**

+ This role is primarily standard day shift, Monday - Friday. Support of manufacturing as quality issues arise may be required outside of regular working hours.

+ Some travel may be required but expected to be minimal.

**Other Job Details:**

+ Last Date to Apply: June 28, 2021

+ Eligible for Relocation Package

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Quality Assurance and Control

Posted: 2021-06-24 Expires: 2021-07-25
Sponsored by:
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Quality Assurance Manager

Andover, MA 01810

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